NCT07275918招募中1 期
A Randomized, Double-Blind, Placebo-Controlled Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of SA1211 Injection in Healthy Participants and Participants With Chronic Hepatitis B
Suzhou Siran Biotechnology Co.,Ltd.1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2025年11月25日最近更新:
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Number of participants with AEs, SAEs and abnormal laboratory testings
研究概览
简要总结
The goal of this clinical trial is to evaluate the safety, tolerability, immunogenicity and Pharmacokinetics (PK) characteristics of SA1211 Injection in healthy volunteers (Part A) and participants with chronic hepatitis B (CHB, Part B), and assess its preliminary efficacy in participants with chronic hepatitis B (CHB). The main questions it aims to answer are:
What are the safety, tolerability, immunogenicity and PK characteristics of a single subcutaneous injection of SA1211 Injection in healthy volunteers (Part A)? What are the safety, tolerability, immunogenicity and PK characteristics of multiple subcutaneous injections of SA1211 Injection in participants with CHB (Part B)? What is the preliminary efficacy of SA1211 Injection in participants with CHB (Part B)?
Participants will:
- Part A (healthy volunteers): Receive a single subcutaneous injection of SA1211 Injection or placebo and complete relevant safety, tolerability and PK monitoring as required.
- Part B (participants with CHB): Receive multiple subcutaneous injections of SA1211 Injection or placebo and complete relevant safety, tolerability, PK monitoring and preliminary efficacy assessment as required.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Able to correctly understand and sign the informed consent form in writing.
- •Male or female participants.
- •For healthy participants: aged 18-55 years old (inclusive of the cut-off values).
- •For participants with chronic hepatitis B (CHB): aged 18-65 years old (inclusive of the cut-off values).
- •Body Mass Index (BMI) meets the following requirements.
- •For healthy participants: within the range of 18-28 kg/m² (inclusive of the cut-off values).
- •For participants with chronic hepatitis B (CHB): within the range of 18-32 kg/m² (inclusive of the cut-off values).
- •During the screening period, the results of the following examinations are either normal or abnormal but not clinically insignificant:
- •- Clinical laboratory tests: complete blood count, blood biochemistry, coagulation function, urine routine. Thyroid function test. 12-lead electrocardiogram (ECG). Abdominal ultrasound. Posteroanterior chest X-ray.
- •For participants with chronic hepatitis B (CHB): documented hepatitis B virus (HBV) infection for at least 6 months before screening, with positive hepatitis B surface antigen (HBsAg) and/or positive HBV deoxyribonucleic acid (HBV DNA).
- •For female participants of childbearing potential: must not be pregnant or lactating, and agree to use effective contraception during the study period.
- •For male participants of childbearing potential: agree to use effective contraception during the study period to ensure effective contraception for their sexual partners.
排除标准
- •Participants with concurrent hepatitis C virus (HCV), human immunodeficiency virus (HIV) or syphilis infection; or those previously diagnosed with hepatitis A, D, or E who have not been cured.
- •Participants with severe diseases, including but not limited to diseases of the nervous, cardiovascular, hematological and lymphatic, immune, renal, hepatic, thyroid, gastrointestinal, respiratory, metabolic, and skeletal systems, as well as a history of malignant tumors.
- •Participants with severe mental illness or uncontrolled mental disorders, including but not limited to schizophrenia, bipolar disorder, or depression.
- •Participants with a systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg at screening, who are deemed unsuitable for the study by the investigator.
- •Participants who have undergone major surgery within 6 months before screening, or plan to undergo surgery during the study period.
- •Participants with severe infection or trauma within 4 weeks before screening.
- •Participants with a severe allergic constitution, or a confirmed allergy to this product or its formulation components.
- •Participants who smoked more than 5 cigarettes per day or the equivalent amount of tobacco within 3 months before screening.
- •Participants deemed unsuitable for the trial by the investigator due to other factors.
研究组 & 干预措施
Chronic Hepatitis B
Experimental
干预措施: SA1211 injection placebo (Drug)
Healthy Participants
Experimental
干预措施: SA1211 injection (Drug)
Healthy Participants
Experimental
干预措施: SA1211 injection placebo (Drug)
Chronic Hepatitis B
Experimental
干预措施: SA1211 injection (Drug)
结局指标
主要结局
Number of participants with AEs, SAEs and abnormal laboratory testings
时间窗: Approximate 24 weeks
AEs: Adverse Events. SAEs: Serious Adverse Events.
次要结局
- Cmax: maximum concentration(Pre-dose, multiple time-points post dose until 48 hours)
- Tmax(Pre-dose, multiple time-points post dose until 48 hours)
- AUC0-t(Pre-dose, multiple time-points post dose until 48 hours)
- AUC0-inf(Pre-dose, multiple time-points post dose until 48 hours)
- t1/2(Pre-dose, multiple time-points post dose until 48 hours)
- λz(Pre-dose, multiple time-points post dose until 48 hours)
- Vd/F(Pre-dose, multiple time-points post dose until 48 hours)
- CL/F(Pre-dose, multiple time-points post dose until 48 hours)
- Css (Steady-State Concentration)(Pre-dose, multiple time-points post dose until 48 hours)
- DF (Degree of Fluctuation)(Pre-dose, multiple time-points post dose until 48 hours)
- The number of participants with chronic hepatitis B (CHB) who achieved hepatitis B surface antigen (HBsAg) clearance(Approximate 24 weeks)
- Maximum HBsAg Decline in CHB Participants Within 24 Weeks (log10)(Approximate 24 weeks)
- The number of CHB Participants with HBsAg Seroconversion at each assessment time Point within 24 weeks(Approximate 24 weeks)
- The number of CHB participants who achieved HBeAg seronegativity at each assessment time point within 24 weeks(Approximate 24 weeks)
- The number of participants with immunogenicity (i.e., anti-drug antibodies [ADAs])(Approximate 24 weeks)
- The change in QTcF relative to baseline and the change relative to placebo(Approximate 24 weeks)
研究者
研究点 (1)
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